A Phase 2 Extension of Study GCS-100-CS-4003

Launched by LA JOLLA PHARMACEUTICAL COMPANY · Jan 7, 2015

Keywords

ClinConnect Summary

Galectin-3 contributes to fibrosis, is elevated in patients with ESRD, and correlates with adverse outcomes (de Boer et. al., 2011, Dang et. al., 2012, Fernandes Bertocchi et. al., 2008, Henderson et. al., 2008). Animal models with genetic knockout of galectin-3 demonstrate a reduction in structural and functional deficits in the kidney (Dang et. al., 2012, Fernandes Bertocchi et. al., 2008, Henderson et. al., 2008). GCS-100 is a galectin-3 antagonist that has been shown to reduce fibrosis pre-clinically. Based on the role of galectin-3 and fibrosis in kidney disease, the Sponsor believes G...

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Eligibility criteria

• Inclusion Criteria:
• • 1. Subject is capable of understanding the purpose and risks of the study and is able to provide written informed consent
• • 2. Subject was enrolled in GCS-100-CS-4003.
• Exclusion Criteria:
• • 1. Subject experienced a Grade 3 or worse adverse event related to GCS-100 in clinical study GCS-100-CS-4003.
• • 2. Systolic blood pressure ≤90 mmHg and ≥160 mmHg and diastolic blood pressure ≤40 mmHg and ≥100 mmHg at screening
• 3. Subject has clinical laboratory values of:
• • Hemoglobin: ≤9 g/dL
• • Total bilirubin: \>1.5X the upper limit of normal (ULN)
• • ALT and/or AST: \>2.5X ULN
• • 4. Subject has a concomitant disease or condition, including laboratory abnormalities, which, in the opinion of the investigator, could interfere with the conduct of the study or put the subject at unacceptable risk.
• • 5. Subject who may require renal replacement therapy within the next 2 months, at the discretion of the investigator.